Metatarsal fixation device, system and method

ABSTRACT

A metatarsal fixation device is provided for fixation of osteotomy or fracture of a distal metatarsal metaphysis bone of the human foot and for fixation of an associated capsule to the metatarsal head. The device includes a metallic bone plate with a series of screw holes along an elongated portion of the plate and a combination of a singular screw hole and a resilient clamp on an end of the elongated portion. The resilient clamp has two arched resilient arms extending laterally outward from an end of the elongated portion. Each arm has a plurality of spikes on an inner surface thereof providing points of contact that compress and attach a metatarsal phalangeal joint capsule portion to the medial and/or lateral aspect of the metatarsal head, thereby facilitating realignment of the metatarsophalangeal joint and respective digit. The resilient arms are biased to grasp lateral sides of a metatarsal head and any associated capsule portion.

RELATED APPLICATIONS

This patent application is a continuation application of U.S. patentapplication Ser. No. 14/820,139, filed Aug. 6, 2015, which is acontinuation application of U.S. patent application Ser. No. 13/653,600,now U.S. Pat. No. 9,101,421, issued Aug. 11, 2015, which claims thebenefit of and/or priority under 35 U.S.C. §119(e) to U.S. ProvisionalPatent Application Ser. No. 61/569,605 filed Dec. 12, 2011, entitled“Metatarsal Bone Fixation Device, System and Method” the entire contentsof which is specifically incorporated herein by this reference.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to surgically implanted devices forfixation of human bones and associated tissue, and particularly tosurgically implanted devices for fixation of metatarsal bones andassociated tissue. More particularly, the present invention relates tosurgically implanted devices for internal fixation of a distal portionof a metatarsal bone with a metatarsal diaphysis along with any capsularcorrections.

Background

The distal metatarsal metaphysis of the human foot is a very common siteof fracture as well as repositional osteotomy for correction ofdeformities as well as other reasons. Osteotomy to provide shortening ofa metatarsal is commonly performed to decrease plantar forefoot pressureat the site of a metatarsal head. Shortening osteotomy is most commonlyperformed on central metatarsals. Shortening the metatarsal shortens thelever and decreases the pressure at the plantar forefoot generatedduring the propulsive phase of gait. Shortening osteotomy can alleviatepain caused by excessive pressure due to a relatively long metatarsal.Shortening osteotomy can also help heal plantar skin keratosis orulceration due to excessive pressure. Shortening osteotomy is oftenperformed in combination with hammertoe corrective procedures.

Stable fixation of the metatarsal head fragment to the diaphysis (shaft)of the metatarsal in order to provide appropriate correction and idealanatomic osteotomy location can be challenging and inadequate withcurrent devices available. Osteotomy orientation has currently evolvedto facilitate fixation while sacrificing ideal correction and idealosteotomy anatomic location. A pure segmental shortening osteotomyperformed at the distal metaphysis is ideal but very difficult tofixate. The distal fragment is small and current fixation devices do notadequately fixate this fragment in order to stabilize the metaphysealosteotomy.

To address this problem, currently a more proximal segmental shorteningosteotomy is performed so a dorsal plate can be used with at least twoscrews to engage the distal fragment. Plates are available with bothnon-locking and locking screws to engage the bone. This more proximalosteotomy results in diaphyseal bone shortening. Metaphyseal bone has agreater healing potential than diaphyseal bone and is therefore thepreferable location for osteotomy. Furthermore, the more proximalosteotomy is potentially stressed by a longer lever distal to theosteotomy.

The most common osteotomy for shortening of the central metatarsals is along oblique osteotomy from distal dorsal to proximal plantar. This ispartially a metaphyseal osteotomy and facilitates fixation from dorsalto plantar with isolated screws or pins. The osteotomy orientationunfortunately often results in plantar displacement of the distalfragment with the shortening. The distal dorsal cortical spike is alsosubject to fracture at the fixation site which can result indisplacement of the osteotomy.

Osteotomies to displace a metatarsal head laterally or medially areoften performed to correct bone prominence of the first (hallux abductovalgus/bunion deformity) or fifth metatarsal (tailor's bunion/bunionettedeformity) in the transverse plane of the foot. Fixation of themetatarsal head fragment to the shaft fragment is again facilitated byosteotomy orientation. Osteotomy configurations include: oblique,chevron, chevron with longer arm dorsal or plantar, “Z”/scarf andothers. Current internal fixation options include: k-wires, screws,plates, wire, staples. These osteotomies are all subject to displacementwith current fixation options as the distal fragment is difficult tosecure with current devices. The aging population and associateddecrease in bone density further increases the potential loss offixation with current techniques and devices. The problem continues tobe inadequate stabilization of an osteotomy due to suboptimal fixationof the metatarsal head fragment.

Moreover, often associated with metatarsal deformities are respectivedigital deformities. Mal-alignment in the transverse plane includesdigits deviated medially or laterally from their proper position. Whenmetatarsal realignment osteotomies are performed, capsular correctionsmust also be included for realignment of the respective digit. Thecapsular corrections include releasing or lengthening the tight softtissue preventing realignment and tightening the capsule/ligament on theside where it is lax. Tightening of the capsule is performed by removinga section or advancing the lax capsule from its original attachment andreattaching. The standard means of securing is sutures. Capsuletightening is difficult when adjacent structures prevent access to thesite of repair. Also, suture repair requires exposure. The centralmetatarsophalangeal joints are particularly difficult to performcapsular balancing due to the adjacent joints medial and lateralrestricting exposure.

It is therefore evident from the above that there is a need for asystem, device and method for better fixation of a metatarsal osteotomyor fracture.

It is further evident from the above that there is a need for betterinternal fixation of a distal portion of a metatarsal bone and adiaphysis of the metatarsal bone so as to stabilize an osteotomy orfracture of the metatarsal distal metaphysis.

It is moreover evident from the above that there is a need for a system,device and method for fixation of ligamentous and joint capsular tissueto a metatarsal head particularly in connection with fixation of ametatarsal metaphyseal osteotomy or fracture.

SUMMARY OF THE INVENTION

A bone structure fixation device, system and method of use is providedfor fixation of bones of the foot and hand along with tissue componentcorrection particularly, but not necessarily, for internal fixation of adistal portion of metatarsal bone (e.g. an epiphysis thereof or ametaphysis and epiphysis thereof) with an associated diaphysis (i.e.shaft) of the metatarsal bone so as to stabilize an osteotomy orfracture of the metatarsal bone, and for internal fixation ofligamentous and/or joint capsular tissue performed in connection withthe osteotomy or fracture.

The present invention provides better fixation between a distal portionof a metatarsal bone and its diaphysis in the event of a metaphysealosteotomy or fracture, and/or the need to provide capsular corrections,including releasing or lengthening the tight soft tissue preventingrealignment and tightening the capsule/ligament on the side where it islax. The present metatarsal fixation device therefore provides stablefixation of the diaphyseal segment—with plate and locking screwtechnology, and the metatarsal head fragment via clamping technology,with the clamping technology also providing joint softtissue/capsule/ligament/capsular realignment and/or tightening(correction).

In broad terms, the present metatarsal fixation device comprises ametallic bone fixation plate having a series of threaded locking screwholes along an elongated portion of the plate and a combination of athreaded locking screw hole and a resilient clamp on an end of theelongated portion, the resilient clamp characterized by resilientarched, spiked arms extending transverse to the end of the elongatedportion. The resilient or spring-like arched, spiked arms have a naturalcurvature sized and designed to grasp onto an epiphysis of a metatarsalbone and associated capsule portion or capsular tissue after the armshave been resiliently expanded by an expansion force. After expansion,the resilient, spring-like arms return to a pre-expansion state in orderto clamp, clasp and/or grasp onto the epiphysis (metatarsal head) at themedial and lateral sides thereof and a capsule/ligament portion. Themetatarsal fixation device thus provides stability to a small,potentially unstable metatarsal head fragment as well as providingcapsular/ligament fixation.

The space between the three diaphyseal screws (i.e. along the elongatedportion of the plate) and the distal screw (i.e. proximate the clamp),with medial and lateral arms, can be the site of an osteotomy forsegmental shortening, displacement osteotomy, or fracture. Thismetaphyseal site of bone healing is protected from potentiallyhealing-disruptive stresses by this invention. The spiked arms providefixation of any capsular/ligament correction to the epiphysis.

In a particular form, a metatarsal fixation device is defined by agenerally rigid metallic plate having an elongated portion with circularthreaded holes spaced there-along to receive threaded bone screws. Thethreaded holes are preferably, but not necessarily, evenly spaced alongthe elongated portion beginning at one end thereof. A clasp and asingular circular threaded hole are provided at an opposite end of theelongated portion. The clasp is defined by two arms that project fromeach side of the elongated portion end and 180° from each other. Eacharm is curved, arched or arced to create a general “U” shape and/or hasa curvature that mimics a curvature of an epiphysis. The armspreferably, but not necessarily, project in the same direction as thebone screws. In this manner, the shape of the elongated portion andclasp (i.e. the plate) is nearly anatomically congruous to themetatarsal. The end of each arm incorporates spikes to engage themetatarsal head and capsule/ligament medially and laterally.

The spikes on each arm's interior serve as a point of fixation for thecapsule advancement if the arms are used extra capsularly. The side ofthe metatarsophalangeal joint in need of capsular tightening may havethe capsule released from the native attachment to the metatarsal head.The capsule is then pulled proximally to pull the digit into properalignment. The present plate is applied extracapsularly and the armsproviding compression, securing the advanced capsule back to themetatarsal head with the digit in proper alignment. Minimal exposure isrequired between the capsule and adjacent soft tissues to insert thefixation plate's arm and the implant instrument.

The implant instrument comprises pliers specifically designed to expandthe arms about the medial and lateral aspects of the metatarsal headthen release the arms causing the spikes to clamp, grasp of clasp ontoand/or into the medial and lateral aspect of the metatarsal head and anyligamentous/capsule tissue. The plate arms with their associated spikesalong with the isolated screw engage the metatarsal head bone fragmentwhile the three opposite end screw holes of the elongated portion andits screws engage the metatarsal diaphysis. The space between theisolated screw hole and the series of three screw holes spans themetatarsal metaphyseal osteotomy or fracture site.

The present fixation device serves two purposes. One purpose is thefixation of the metatarsal metaphyseal osteotomy or fracture. The otherpurpose is the fixation of the capsule to the metatarsal head.

While the present invention is applicable to other bone structures, thepresent fixation device is described with reference to metatarsal bones,it being understood that the present fixation device may be used forother bones and/or bone structures of the body.

Further aspects of the present invention will become apparent fromconsideration of the drawings and the following description of preferredembodiments of the invention. A person skilled in the art will realizethat other embodiments of the invention are possible and that thedetails of the invention can be modified in a number of respects withoutdeparting from the inventive concept. The following drawings anddescription are to be regarded as illustrative in nature and notrestrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the invention will be better understood by reference tothe accompanying drawings which illustrate presently preferredembodiments of the invention, wherein:

FIG. 1 is a top view of bones of a human foot particularly showing thetarsals, metatarsals and phalanges thereof;

FIG. 2 is an oblique view of an embodiment of a metatarsal fixationdevice fashioned in accordance with the present principles;

FIG. 3 is a side oblique view of the metatarsal bone fixation device ofFIG. 2;

FIG. 4 is a top plan view of the metatarsal bone fixation device of FIG.2;

FIG. 4A is a sectional view of the metatarsal bone fixation device ofFIG. 2 taken along line 4A-4A of FIG. 4;

FIG. 5 is a side view of the metatarsal bone fixation device of FIG. 2taken along line 5-5 of FIG. 4;

FIG. 6 is a bottom view of the metatarsal bone fixation device of FIG. 2taken along line 6-6 of FIG. 5;

FIG. 7 is a front view of the metatarsal bone fixation device of FIG. 2taken along line 7-7 of FIG. 5;

FIG. 7A is an enlarged front view of a portion of the metatarsal bonefixation device of FIG. 2 taken along circle 7A of FIG. 7, particularlyshowing attachment structures of an arm thereof;

FIG. 7B is an enlarged sectional view of a front portion of themetatarsal fixation device of FIG. 2 taken along line 7B-7B of FIG. 7;

FIG. 8 is a front view of the metatarsal bone fixation device of FIG. 2illustrating the manner in which the metatarsal bone fixation deviceflexes for attachment to a metatarsal head or to the metatarsal head andthe metatarsal phalangeal joint capsule to the medial or lateral aspectof the metatarsal head;

FIG. 9 is an oblique view of another embodiment of a metatarsal bonefixation device fashioned in accordance with the present principleswherein an attachment portion of the device is angled or offset relativeto a longitudinal axis of a plate of the device;

FIG. 10 is a top view of the metatarsal bone fixation device of FIG. 9;

FIG. 11 is a front view of the metatarsal bone fixation device of FIG. 9taken along line 11-11 of FIG. 10;

FIG. 12 is an oblique of another embodiment of a metatarsal bonefixation device fashioned in accordance with the present principleswherein an attachment portion of the device is angled or offset relativeto a longitudinal axis of a plate of the device;

FIG. 13 is a top view of the metatarsal bone fixation device of FIG. 12;

FIG. 14 is a front view of the metatarsal bone fixation device of FIG.12 taken along line 12-12 of FIG. 13;

FIG. 15 is an oblique view of another embodiment of a metatarsal bonefixation device fashioned in accordance with the present principles;

FIG. 16 is a top view of the metatarsal bone fixation device of FIG. 15;

FIG. 17 is a front view of the metatarsal bone fixation device of FIG.15 taken along line 17-17 of FIG. 16;

FIG. 18 is a top view of an another embodiment of a metatarsal bonefixation device fashioned in accordance with the present principles, anattachment portion of the device angled or offset relative to alongitudinal axis of a plate of the device;

FIG. 19 is a top view of an another embodiment of a metatarsal bonefixation device fashioned in accordance with the present principles, anattachment portion of the device angled or offset relative to alongitudinal axis of a plate of the device;

FIG. 20 is an oblique view of the metatarsal bone fixation device ofFIG. 1 affixed to a metatarsal and, particularly to a diaphysis andepiphysis of the metatarsal for the stabilization of a metaphysealfracture thereof, the arms of the attachment portion of the metatarsalbone fixation positioned about and onto the epiphysis, the jagged linerepresenting a fracture/osteotomy;

FIG. 21 is an end view of an exemplary instrument for installing anyembodiment of a metatarsal bone fixation device, the installationinstrument depicted expanding the arms and attachment structures of theattachment portion of the metatarsal fixation device prior to affixationof the metatarsal bone fixation device onto the metatarsal head via jawsof the installation instrument; and

FIG. 22 is an enlarged end view of the metatarsal head with a metatarsalbone fixation device engaging the metatarsal head with its attachmentstructures.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 1, there is depicted for purposes of illustration adiagram of the general bones of a human foot 10 particularly a righthuman foot as seen viewed the top. The human foot has tarsal bones ortarsals including the calcaneous C and the talus T, the metatarsal bonesor metatarsals and phalange bones or phalanges. There are generally fivemetatarsals (M1, M2, M3, M4 and M5) each having a base, shaft and head,and generally five phalanges each having a proximate, middle and distalportion. While the present bone fixation device may be used for variousbones of the body, it is especially configured for the fixation of ametatarsal. It is thus with respect to a metatarsal that the presentinvention will be described.

Referring now to FIGS. 1-8, there is depicted several views of a bonefixation device generally designated 20. As indicated, the bone fixationdevice 20 is particularly suited for and is thus fashioned as ametatarsal fixation device 20. It should be appreciated however, thatthe metatarsal fixation device 20 and/or its principles are applicableto other bones of the foot as well as to bones of the hand. Themetatarsal bone fixation device 20 is characterized by a plate 22 havingan elongated portion 24 and a clamping portion 26. The clamping portionor clamp 26 is characterized by arms 28 and 30 that extend from lateralor transverse sides of a distal end (as implanted) of the elongatedportion 24. FIG. 8 illustrates the resilient properties of the clampingportion 26 that allow the clamping portion 26 to naturally compressagainst a metatarsal head. As seen, the arms 28, 30 initially extendtransverse to the distal end of the elongated portion 24 then curve orarch downward and away from the end of the elongated portion 24 togenerally form a U shape.

The plate 22 is composed of a generally rigid but resilient,biocompatible metal that is preferably, but not necessarily,approximately 1 mm thick. The underside of the plate 22 or the surfaceof the plate 22 that contacts the bone surface may include a slightradius from medial to lateral to match the contour of the bone such asdiscerned in FIG. 4A.

The elongated portion 24 of the plate 22 has an anchoring sectionfashioned as a plurality of threaded holes (holes 33, 34, 35) thatextend along the longitudinal length of the elongated portion 24 from aproximate end 36 thereof towards a distal end thereof (i.e. the clampingportion 26). It should be appreciated that the anchoring section mayinclude more or less threaded holes with three threaded holes beingpreferred. The three threaded holes 33, 34, 35 are depicted at one endof the elongated portion 24 arranged in linear orientation and evenlyspaced. Other configurations, however, may be used and are contemplated.

A single threaded hole 32 is centered at the distal end of the plate 22at the clamping portion 26. The single or isolated hole 32 is separatedfrom the next hole 33 of the anchoring section by an appropriatedistance (which in the case of a metatarsal, is approximately 10 mm).Each of the threaded holes 33, 34, 35, 32 is for receiving threaded bonescrews when the device is implanted/attached. This is seen in FIG. 20where bone screws 990 extend from the holes 32, 33, 34, 35, and into thebone when the device 20 is installed. The bone screws 990 preferablyhave threaded shafts 991 that extend into and grip the bone. Referringto FIG. 4A, the threaded hole 32 is shown in greater detail as exemplaryof all of the threaded holes 32, 33, 34, and 35.

The clamping portion 26 is characterized by two arms 28, 30 that projectfrom lateral sides of the distal end of the elongated plate 24. The arms28, 30 project transverse from the lateral sides of the distal end ofthe elongated plate 24 then extend downwardly to generally form a Ushape. The arm 28 includes an attachment structure 39 on an insidesurface thereof. The attachment structure 39 is defined by a pluralityof spikes or spike-like structures 38 a, 38 b, 38 c that project inwardfrom the inside surface of the arm 28. Preferably, but not necessarily,the spikes 38 a, 38 b, 38 c are the same shape and size. In one form,the spikes 38 a, 38 b, 38 c protrude 1 mm from the inner surface of theam 28. It should be appreciated however, that the spikes of theattachment structure 39 may be shaped and sized differently if desired.Also, the spikes 38 a, 38 b, 38 c are preferably, but not necessarily,evenly spaced relative to each other beginning proximate an end of thearm 28 distal the elongated plate 24. The spikes provide points ofcontact with the metatarsal head affording various points of fixation.The spikes 38 a, 38 b, 38 c are shaped and sized to grasp or clampagainst, affix or attach to, a lateral side of a metatarsal head.Additionally, the spikes 38 a, 38 b, 38 c grasp, clamp or compressagainst a capsule or a capsule portion of the metatarsal joint whichthen affixes or attaches the capsule or capsule portion of themetatarsal joint to a lateral side of the metatarsal head, therebyfacilitating realignment of the metatarsalsophalageal joint andrespective digit.

The arm 30 includes an attachment structure 41 on an inside surfacethereof in like manner as the attachment structure 39 of the arm 28. Theattachment structure 41 is defined by a plurality of spikes orspike-like structures 40 a, 40 b, 40 c that project inward from theinside surface of the arm 30. Preferably, but not necessarily, thespikes 40 a, 40 b, 40 c are the same shape and size. In one form, thespikes 40 a, 40 b, 40 c protrude 1 mm from the inner surface of the am30. It should be appreciated however, that the spikes of the attachmentstructure 41 may be shaped and sized differently if desired. Also, thespikes 40 a, 40 b, 40 c are preferably, but not necessarily, evenlyspaced relative to each other beginning proximate an end of the arm 30distal the elongated plate 24. The spikes provide points of contact withthe metatarsal head affording various points of fixation. The spikes 40a, 40 b, 40 c are shaped and sized to grasp or clamp against, affix orattach to, lateral sides of a metatarsal head. Additionally, the spikes40 a, 40 b, 40 c grasp, clamp or compress against a capsule or a capsuleportion of the metatarsal joint which then affixes or attaches thecapsule or capsule portion of the metatarsal joint to a lateral side ofthe metatarsal head, thereby facilitating realignment of themetatarsalsophalageal joint and respective digit.

The arms 28, 30 are resilient or spring-like such that they return totheir original shape after being spread, such as during implantation ofthe device. Particularly, the resilient arms 28, 30 are configured andshaped to compress, grasp or clamp against or attach to the metatarsalhead under their own natural resilient force. As such, the attachmentstructures 39, 41 (and, particularly the spikes 38, 40 of the attachmentstructures 39, 41) contact, compress and grasp or clamp onto themetatarsal head with or without clamping or securing of a capsule orcapsule portion depending on whether the clamping portion 26 is usedextracapsularly (with capsule securing) or intracapsularly (withoutcapsule securing). As illustrated in FIG. 8, the natural clampingposition or state of the arms 28, 30 (i.e. clamping portion 26) isrepresented by the unbroken lines and a temporary expanded position orstate of the arms 28, 30 is represented by the broken lines. The arms28, 30 are expanded during implantation of the device as per aninstrument 950 illustrated in FIG. 21 which is described more fullybelow. In summary, the expanded position is achieved by forciblyspreading the arms 28, 30 as via the instrument 950.

It should be appreciated that the metatarsal fixation device 20 is usedwhere the metatarsal head or epiphysis is attached to the metatarsaldiaphysis (bone shaft) along its original longitudinal axis such asshown in FIG. 20 where a fracture of the metaphysis of the metatarsalhas been repaired through the use of the metatarsal fixation device 20.In FIG. 20, the capsule and other metatarsal joint tissue is not shown.In cases such as rectification of a deformity, injury or theramifications of disease where fixation of the epiphysis isintentionally not aligned with the original longitudinal axis of thediaphysis, a modified metatarsal fixation device is used.

Referring now to FIGS. 9-11, there is depicted a metatarsal fixationdevice 120 fashioned in like manner to the metatarsal fixation device 20of FIGS. 1-8 but with a modification necessary for use in cases wherefixation of the epiphysis is intentionally not aligned with the originallongitudinal axis of the diaphysis. The metatarsal fixation device 120is characterized by a plate 122 having an elongated portion 124 and aclamping portion 126. The clamping portion or clamp 126 is characterizedby arms 128 and 130 that extend from lateral or transverse sides of adistal end (as implanted) of the elongated portion 124. As seen in FIG.11, the arms 128, 130 initially extend transverse to the distal end ofthe elongated portion 124 then curve or arch downward and away from theend of the elongated portion 124 to generally form a U shape.

The plate 122 is composed of a generally rigid but resilient,biocompatible metal that is preferably, but not necessarily,approximately 1 mm thick. The underside of the plate 122 or the surfaceof the plate 122 that contacts the bone surface may include a slightradius from medial to lateral to match the contour of the bone such asshown in FIG. 4A with respect to the metatarsal fixation device 20.

The elongated portion 124 of the plate 122 has an anchoring sectionfashioned as a plurality of threaded holes (holes 133, 134, 135) thatextend along the longitudinal length of the elongated portion 124 from aproximate end 136 thereof towards a distal end thereof (i.e. theclamping portion 126). It should be appreciated that the anchoringsection may include more or less threaded holes with three threadedholes being preferred. The three threaded holes 133, 134, 135 aredepicted at one end of the elongated portion 124 arranged in linearorientation and evenly spaced. Other configurations, however, may beused and are contemplated.

A single threaded hole 132 is centered at the distal end of the plate122 at the clamping portion 126. The single or isolated hole 132 isseparated from the next hole 133 of the anchoring section by a crook orangled section 125 providing an appropriate distance (which in the caseof a metatarsal, is approximately 10 mm). Each of the threaded holes132, 133, 134, 135, are for receiving threaded bone screws when thedevice is implanted/attached in like manner as the metatarsal fixationdevice 20 shown in FIG. 20. The threaded holes 132, 133, 134, 135 arelike the threaded hole 32 shown in FIG. 4A.

The clamping portion 126 is characterized by two arms 128, 130 thatproject from lateral sides of the distal end of the elongated plate 124.The arms 128, 130 project transverse from the lateral sides of thedistal end of the elongated plate 124 then extend downwardly togenerally form a U shape. The arm 128 includes an attachment structure139 on an inside surface thereof. The attachment structure 139 isdefined by a plurality of spikes or spike-like structures 138 a, 138 b,138 c that project inward from the inside surface of the arm 128.Preferably, but not necessarily, the spikes 138 a, 138 b, 138 c are thesame shape and size. In one form, the spikes 138 a, 138 b, 138 cprotrude 1 mm from the inner surface of the am 128. It should beappreciated however, that the spikes of the attachment structure 139 maybe shaped and sized differently if desired. Also, the spikes 138 a, 138b, 138 c are preferably, but not necessarily, evenly spaced relative toeach other beginning proximate an end of the arm 128 distal theelongated plate 124. The spikes provide points of contact with themetatarsal head affording various points of fixation. The spikes 138 a,138 b, 138 c are shaped and sized to grasp or clamp against, affix orattach to, a lateral side of a metatarsal head. Additionally, the spikes138 a, 138 b, 138 c grasp, clamp or compress against a capsule or acapsule portion of the metatarsal joint which then affixes or attachesthe capsule or capsule portion of the metatarsal joint to a lateral sideof the metatarsal head, thereby facilitating realignment of themetatarsalsophalageal joint and respective digit.

The arm 130 includes an attachment structure 141 on an inside surfacethereof in like manner as the attachment structure 139 of the arm 128.The attachment structure 141 is defined by a plurality of spikes orspike-like structures 140 a, 140 b, 140 c that project inward from theinside surface of the arm 130. Preferably, but not necessarily, thespikes 140 a, 140 b, 140 c are the same shape and size. In one form, thespikes 140 a, 140 b, 140 c protrude 1 mm from the inner surface of theam 130. It should be appreciated however, that the spikes of theattachment structure 141 may be shaped and sized differently if desired.Also, the spikes 140 a, 140 b, 140 c are preferably, but notnecessarily, evenly spaced relative to each other beginning proximate anend of the arm 130 distal the elongated plate 124. The spikes providepoints of contact with the metatarsal head affording various points offixation. The spikes 140 a, 140 b, 140 c are shaped and sized to graspor clamp against, affix or attach to, a lateral side of a metatarsalhead. Additionally, the spikes 140 a, 140 b, 140 c grasp, clamp orcompress against a capsule or a capsule portion of the metatarsal jointwhich then affixes or attaches the capsule or capsule portion of themetatarsal joint to a lateral side of the metatarsal head, therebyfacilitating realignment of the metatarsalsophalageal joint andrespective digit.

The arms 128, 130 are resilient or spring-like such that they return totheir original shape after being spread, such as during implantation ofthe device. Particularly, the resilient arms 128, 130 are configured andshaped to compress, grasp or clamp against or attach to lateral sides ofthe metatarsal head under their own natural resilient force. As such,the attachment structures 139, 141 (and, particularly the spikes 138,140 of the attachment structures 139, 141) contact, compress and graspor clamp onto the metatarsal head with or without clamping or securingof a capsule or capsule portion depending on whether the clampingportion 126 is used extracapsularly (with capsule securing) orintracapsularly (without capsule securing). This is the same as thatillustrated in FIG. 8 for the metatarsal fixation device 20.

The crook or angled section 125 of the plate 122 provides an offset ofthe clamping portion 126 relative to the elongated portion 124 relativeto a lateral side of the elongated portion 124. Thus, the longitudinalaxis of the fixed epiphysis is offset a given amount corresponding tothe amount of offset provided by the crook 125 relative to thelongitudinal axis of the diaphysis. The amount of offset may varydepending on the amount of offset required. As such, plates 122 may bemade with different offsets or crooks 125 to accommodate desiredoutcomes.

Referring now to FIGS. 12-14, there is depicted a metatarsal fixationdevice 220 fashioned in like manner to the metatarsal fixation device120 of FIGS. 9-11 but with a crook or angled section 225 that projectsfrom a lateral side of the elongated plate opposite to that of themetatarsal fixation device 120. As such, the metatarsal fixation device220 is used in cases where fixation of the epiphysis is intentionallynot aligned with the original longitudinal axis of the diaphysis. Themetatarsal fixation device 220 is characterized by a plate 222 having anelongated portion 224 and a clamping portion 226. The clamping portionor clamp 226 is characterized by arms 228 and 230 that extend fromlateral or transverse sides of a distal end (as implanted) of theelongated portion 224. As seen in FIG. 14, the arms 228, 230 initiallyextend transverse to the distal end of the elongated portion 224 thencurve or arch downward and away from the end of the elongated portion224 to generally form a U shape.

The plate 222 is composed of a generally rigid but resilient,biocompatible metal that is preferably, but not necessarily,approximately 1 mm thick. The underside of the plate 222 or the surfaceof the plate 222 that contacts the bone surface may include a slightradius from medial to lateral to match the contour of the bone such asshown in FIG. 4A with respect to the metatarsal fixation device 20.

The elongated portion 224 of the plate 222 has an anchoring sectionfashioned as a plurality of threaded holes (holes 233, 234, 235) thatextend along the longitudinal length of the elongated portion 224 from aproximate end 236 thereof towards a distal end thereof (i.e. theclamping portion 226). It should be appreciated that the anchoringsection may include more or less threaded holes with three threadedholes being preferred. The three threaded holes 233, 234, 235 aredepicted at one end of the elongated portion 224 arranged in linearorientation and evenly spaced. Other configurations, however, may beused and are contemplated.

A single threaded hole 232 is centered at the distal end of the plate222 at the clamping portion 226. The single or isolated hole 232 isseparated from the next hole 233 of the anchoring section by a crook orangled section 225 providing an appropriate distance (which in the caseof a metatarsal, is approximately 10 mm). Each of the threaded holes232, 233, 234, 235, are for receiving threaded bone screws when thedevice is implanted/attached in like manner as the metatarsal fixationdevice 20 shown in FIG. 20. The threaded holes 232, 233, 234, 235 arelike the threaded hole 32 shown in FIG. 4A.

The clamping portion 226 is characterized by two arms 228, 230 thatproject from lateral sides of the distal end of the elongated plate 224.The arms 228, 230 project transverse from the lateral sides of thedistal end of the elongated plate 224 then extend downwardly togenerally form a U shape. The arm 228 includes an attachment structure239 on an inside surface thereof. The attachment structure 239 isdefined by a plurality of spikes or spike-like structures 238 a, 238 b,238 c that project inward from the inside surface of the arm 228.Preferably, but not necessarily, the spikes 238 a, 238 b, 238 c are thesame shape and size. In one form, the spikes 238 a, 238 b, 238 cprotrude 1 mm from the inner surface of the arm 228. It should beappreciated however, that the spikes of the attachment structure 239 maybe shaped and sized differently if desired. Also, the spikes 238 a, 238b, 238 c are preferably, but not necessarily, evenly spaced relative toeach other beginning proximate an end of the arm 228 distal theelongated plate 224. The spikes provide points of contact with themetatarsal head affording various points of fixation. The spikes 238 a,238 b, 238 c are shaped and sized to grasp or clamp against, affix orattach to, a lateral side of a metatarsal head. Additionally, the spikes238 a, 238 b, 238 c grasp, clamp or compress against a capsule or acapsule portion of the metatarsal joint which then affixes or attachesthe capsule or capsule portion of the metatarsal joint to a lateral sideof the metatarsal head, thereby facilitating realignment of themetatarsalsophalageal joint and respective digit.

The arm 230 includes an attachment structure 241 on an inside surfacethereof in like manner as the attachment structure 239 of the arm 228.The attachment structure 241 is defined by a plurality of spikes orspike-like structures 240 a, 240 b, 240 c that project inward from theinside surface of the arm 230. Preferably, but not necessarily, thespikes 240 a, 240 b, 240 c are the same shape and size. In one form, thespikes 240 a, 240 b, 240 c protrude 1 mm from the inner surface of theam 230. It should be appreciated however, that the spikes of theattachment structure 241 may be shaped and sized differently if desired.Also, the spikes 240 a, 240 b, 240 c are preferably, but notnecessarily, evenly spaced relative to each other beginning proximate anend of the arm 230 distal the elongated plate 224. The spikes providepoints of contact with the metatarsal head affording various points offixation. The spikes 240 a, 240 b, 240 c are shaped and sized to graspor clamp against, affix or attach to, a lateral side of a metatarsalhead. Additionally, the spikes 240 a, 240 b, 240 c grasp, clamp orcompress against a capsule or a capsule portion of the metatarsal jointwhich then affixes or attaches the capsule or capsule portion of themetatarsal joint to a lateral side of the metatarsal head, therebyfacilitating realignment of the metatarsalsophalageal joint andrespective digit.

The arms 228, 230 are resilient or spring-like such that they return totheir original shape after being spread, such as during implantation ofthe device. Particularly, the resilient arms 228, 230 are configured andshaped to compress, grasp or clamp against or attach to lateral sides ofthe metatarsal head under their own natural resilient force. As such,the attachment structures 239, 241 (and, particularly the spikes 238,240 of the attachment structures 239, 241) contact, compress and graspor clamp onto the metatarsal head with or without clamping or securingof a capsule or capsule portion depending on whether the clampingportion 226 is used extracapsularly (with capsule securing) orintracapsularly (without capsule securing). This is the same as thatillustrated in FIG. 8 for the metatarsal fixation device 20.

The crook or angled section 225 of the plate 222 provides an offset ofthe clamping portion 226 relative to the elongated portion 224 relativeto the lateral side of the elongated portion 224 opposite to the lateralside of the offset of the metatarsal fixation device 120. Thus, thelongitudinal axis of the fixed epiphysis is offset a given amountcorresponding to the amount of offset provided by the crook 225 relativeto the longitudinal axis of the diaphysis. The amount of offset may varydepending on the amount of offset required. As such, plates 222 may bemade with different offsets or crooks 225 to accommodate desiredoutcomes.

It should be appreciated that the metatarsal fixation devices 20, 120,and 220 may be made in various sizes in order to accommodate variationsin anatomy as well as use. In the present case, the metatarsal fixationdevices 20, 120, 220 may come in various sizes for the various sizes ofmetatarsals both with respect to an individual and in general.Variations in the length and curvature of the respective elongatedportions 24, 124, 224 are contemplated as well as thickness, curvatureand length of the respective arms thereof. Each arm thereof is thussized appropriately for the particular bone. In the present metatarsalapplication, each arm may be approximately 2 mm wide. Referring to FIGS.15-17, there is depicted a variation in size for a metatarsal fixationdevice 320, particularly in the size of the clamping portion 326 thereofin order to illustrate that the metatarsal fixation device (or otherbone fixation device) may be fashioned having various dimensions. Theclamping portion 326 of the bone fixation device 320 provides a U shapethat is wider than the U shape of the clamping portions 26, 126, 226 ofthe respective metatarsal fixation devices 20, 120, 220. It should beappreciated that the various components and features of the bonefixation device 320 that are the same or similar to the variouscomponents and features of the bone fixation devices 20, 120, 220 arelabeled in like manner but in the three hundreds.

FIGS. 18 and 19 provide two further metatarsal fixation devices 420 and520 each a variation in size of the two metatarsal fixation devices 120and 220 respectively, and particularly, a variation in size of theirrespective clamping portions 426, 526. It should be appreciated that thevarious components and features of the metatarsal fixation devices 420and 520 that are the same or similar to the various components andfeatures of the bone fixation devices 120 and 220 are labeled in likemanner but in the four and five hundreds respectively. Of course, thebone fixation plate may also have variations in other parts notspecifically shown herein such as variations in the dimensions of theelongated portion of the plate, such as length, width and hole spacing.

With reference to FIG. 20, the metatarsal fixation plate 22 is shownimplanted onto a fractured metaphysis of a metatarsal and thus joiningor holding together the epiphysis to the diaphysis of the fracturedmetatarsal. The attachment structure 39 of the arm 28 engages, contacts,grasps or clasps a portion of the epiphysis, particularly from a middle(e.g. upper) area of the epiphysis around to and extending about alateral side thereof. The attachment structure 41 of the arm 30 engages,contacts, grasps or clasps another portion of the epiphysis,particularly from the middle area of the epiphysis around to andextending about a medial side thereof. Bone screws 990 are shownextending through the various threaded bores of the plate 22 and intothe diaphysis and epiphysis. Particularly the threaded shafts 991 extendinto the metatarsal bone while the heads 992 are retained on the plate22 by the configuration of the bore holes. The arms 28, 30 are shownimplanted in an intracapsular manner (i.e. under the capsule/softtissue/ligament).

While not shown, the arms 28, 30 and the associated attachmentstructures 39, 41 may additionally engage, contact, grasp or clasp aportion of the capsule and/or other tissue or ligament that may havebecome detached, cut and/or modified such as in the case of correctionsto provide lengthening or releasing the soft tissue about themetatarsal. Tightening of the capsule or soft tissue is performed byremoving a section or advancing the lax capsule/soft tissue from itsoriginal attachment and reattaching. The arms 28, 30 would then beimplanted in an extracapsular manner (i.e. over the capsule/softtissue/ligament).

In FIG. 21 an exemplary instrument 950 for implanting the presentfixation device is shown. The instrument 950 is formed by two curvedhandles 951, 952 that are hinged at pivot 953. The first handle 951 hasa distal portion 955 comprising a configured end 957 proximate the pivot953 while the second handle 952 likewise has distal portion 954 having aconfigured end 956 proximate the pivot 953. The configured end 957extends under and around the arm 30 in order to engage and hold the arm30. The configured end 956 extends under and around the arm 28 in orderto engage and hold the arm 28. In this manner, the configured ends 956,957 allow the instrument or tool 950 to hold open and/or spread (bias)the arms 28, 30 for implantation. Once the clamping portion 26 isproperly positioned, the tool 950 releases the arms 28, 30 to allow themto spring or bias onto the metatarsal head MH (epiphysis/capsule) asdepicted in FIG. 22. Variations in the instrument 950 are contemplated.The method of expanding the arms into place by the present instrumentand thus grasping the metatarsal head through release of the expansionforce can also be accomplished by additional methods.

The elongated portion and the clamping portion of the present fixationdevice are preferably, but not necessarily, anatomically congruous tothe associated metatarsal parts. As shown in FIG. 20, the plate isattached to the metatarsal diaphysis with the series of locking screwsalong the elongated portion, and to the metatarsal head by one lockingscrew and the two attachment structures of the arms. The area of theplate between the series of holes of the elongated portion and theisolated hole of the clamping portion spans the metatarsal metaphysismending an area of osteotomy or fracture.

Some variations of the invention will occur to those skilled in the art.Without being exhaustive, variations include the use of non-lockingscrews and different sizes of screws. The plate size and shape may varyto match the anatomy. The angle of the arms with respect to thelongitudinal portion of the plate may vary. All such variations areintended to be within the scope and spirit of the invention. Shown areexemplary embodiments only.

It should also be appreciated that although the present bone fixationdevice has been shown and described in particularity with respect to ametatarsal or foot bones, it is applicable to metacarpal or hand bones;those bones being very similar in anatomy.

What is claimed is:
 1. A plate for fixing an osteotomy or fracture of abone comprising: an elongate portion defining a proximate end and adistal end, the elongate portion configured to extend along a shaft ofthe bone having the osteotomy or fracture; a plurality of threaded boresdisposed along the elongate portion; a singular threaded bore disposedat the distal end of the elongate portion, wherein the singular threadedbore is centered in the distal end of the elongate portion; and a clampdisposed at the distal end of the elongate portion with a sectionadjacent to the clamp and angled such that the clamp is offset from theelongate portion at a lateral side of the elongate portion, the clamphaving: a first resilient arm extending outwardly and downwardly from alateral side of the distal end of the elongate portion; a secondresilient arm extending outwardly and downwardly from a medial side ofthe distal end of the elongate portion; a first plurality of attachmentstructures extending outwardly from an inner surface of the firstresilient arm; and a second plurality of attachment structures extendingoutwardly from an inner surface of the second resilient arm; wherein thefirst and second resilient arms are normally biased to compress againstthe lateral and medial sides of a head of the bone having the osteotomyor fracture and any associated soft tissue.
 2. The plate of claim 1,wherein the first and second resilient arms generally form a U shape. 3.The plate of claim 1, wherein: the first plurality of attachmentstructures comprise a first plurality of spikes; and the secondplurality of attachment structures comprise a second plurality ofspikes.
 4. The plate of claim 3, wherein: the first plurality of spikescomprises three spikes; and the second plurality of spikes comprisesthree spikes.
 5. The plate of claim 4, wherein the three spikes of thefirst plurality of spikes and the three spikes of the second pluralityof spikes are all the same size and shape.
 6. A plate for fixing anosteotomy or fracture of a bone comprising: an elongate portion defininga proximate end and a distal end, the elongate portion configured toextend along a shaft of the bone having the osteotomy or fracture; aplurality of threaded bores disposed along the elongate portion; asingular threaded bore disposed at the distal end of the elongateportion, wherein the singular threaded bore is centered in the distalend of the elongate portion; and a clamp disposed at the distal end ofthe elongate portion, offset from a longitudinal axis of the elongateportion at a medial side of the elongate portion with a section adjacentto the clamp and angled such that the clamp is offset from the elongateportion at a lateral side of the elongate portion the clamp having: afirst resilient arm extending outwardly and downwardly from a lateralside of the distal end of the elongate portion; a second resilient armextending outwardly and downwardly from a medial side of the distal endof the elongate portion; a first plurality of attachment structuresextending outwardly from an inner surface of the first resilient arm;and a second plurality of attachment structures extending outwardly froman inner surface of the second resilient arm; wherein the first andsecond resilient arms are normally biased to compress against thelateral and medial sides of a head of the bone having the osteotomy orfracture and any associated soft tissue.
 7. The plate of claim 1,wherein an under surface of the elongate portion is curved medially tolaterally.
 8. A plate for fixing an osteotomy or fracture of ametatarsal comprising: an elongate portion defining a proximate end anda distal end, the elongate portion configured to extend along ametatarsal shaft of the metatarsal having the osteotomy or fracture; aplurality of threaded bores disposed in and along the elongate portion;a singular threaded bore disposed at the distal end of the elongateportion, wherein the singular threaded bore is centered in the distalend of the elongate portion; and a clamping portion disposed on thedistal end of the elongate portion with a section adjacent to the clampand angled such that the clamp is offset from the elongate portion at alateral side of the elongate portion, the clamping portion having: afirst resilient arm extending outwardly and downwardly from a lateralside of the distal end of the elongate portion; a second resilient armextending outwardly and downwardly from a medial side of the distal endof the elongate portion; a first plurality of attachment structuresextending outwardly from an inner surface of the first resilient arm;and a second plurality of attachment structures extending outwardly froman inner surface of the second resilient arm; wherein the first andsecond resilient arms are normally biased to compress against thelateral and medial sides of a metatarsal head of the bone having theosteotomy or fracture and any associated soft tissue.
 9. The plate ofclaim 8, wherein the first and second resilient arms generally form a Ushape.
 10. The plate of claim 9, wherein: the first plurality ofattachment structures comprise a first plurality of spikes; and thesecond plurality of attachment structures comprise a second plurality ofspikes.
 11. The plate of claim 10, wherein: the first plurality ofspikes comprises three spikes; and the second plurality of spikescomprises three spikes.
 12. The plate of claim 11, wherein the threespikes of the first plurality of spikes and the three spikes of thesecond plurality of spikes are all the same size and shape.
 13. A platefor fixing an osteotomy or fracture of a metatarsal comprising: anelongate portion defining a proximate end and a distal end, the elongateportion configured to extend along a metatarsal shaft of the metatarsalhaving the osteotomy or fracture; a plurality of threaded bores disposedin and along the elongate portion; a singular threaded bore disposed atthe distal end of the elongate portion, wherein the singular threadedbore is centered in the distal end of the elongate portion; and aclamping portion disposed on the distal end of the elongate portionfurther comprising: a section adjacent to the distal end of the elongateportion and the clamping portion, with a section adjacent to the clampand angled such that the clamp is offset from the elongate portion at alateral side of the elongate portion, the clamping portion having: afirst resilient arm extending outwardly and downwardly from a lateralside of the distal end of the elongate portion; a second resilient armextending outwardly and downwardly from a medial side of the distal endof the elongate portion; a first plurality of attachment structuresextending outwardly from an inner surface of the first resilient arm;and a second plurality of attachment structures extending outwardly froman inner surface of the second resilient arm; wherein the first andsecond resilient arms are normally biased to compress against thelateral and medial sides of a metatarsal head of the bone having theosteotomy or fracture and any associated soft tissue.
 14. The plate ofclaim 13, wherein an under surface of the elongate portion is curvedmedially to laterally.